GLOBAL 1136-42-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295006992), received between Jul 25, 2017 and Aug 24, 2026 — classified as 55 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to failed rotator cuff. Total to reverse.Affected Side: Left Shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50415852 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE GLOBAL ADVANTAGE IMPLANTS WERE REVISED DUE TO THE PATIENT HAVING MULTIPLE DISLOCATIONS. THE ANATOMIC IMPLANTS WERE REPLACED WITH ENHANCE REVERSE IMPLANTS. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. PROCEDURE WAS SMOOTH AND WENT ACCORDING TO PLAN. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25069473 ↗
• InjuryFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHOULDER DISLOCATING, CONVERSION FROM GLOBAL UNITE TO DELTA XTEND. NO DELAY IN CASE. REMOVAL WENT EXCELLENT, CONVERSION WENT WELL. DOI-(B)(6) 2014, DOR-(B)(6) 2026, AFFECTED SIDE-UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24388931 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM ANATOMIC TO REVERSE DUE TO ROTATOR CUFF FAILING OVERTIME. NO FURTHER INFORMATION AVAILABLE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24149862 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CUFF TEAR WITH ANATOMIC GLOBAL ADVANTAGE IN PLACE. GLENOID AND HEAD WERE REMOVED. CTA WAS IMPLANTED. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23790141 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUBSCAP FAILURE. IT WAS PUT IN REVERSE. THIS WAS A SUBSCAP FAILURE NOT CEMENT ISSUE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23401366 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INCOMPETENT ROTATOR CUFF SO IMPLANT WAS REVISED FROM A PRIMARY TOTAL SHOULDER TO A REVERSE TOTAL SHOULDER. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23346405 ↗
• MalfunctionOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GLOBAL ANATOMIC IMPLANTED ON (B)(6) 2019. POST OPERATIVELY THE HEAD DISLODGED FROM PROXIMAL BODY WHILST PATIENT WAS IN BED. GLOBAL UNITE ANATOMIC ANCHOR PEG GLENOID, GLOBAL UNITE HEAD, AND GLOBAL UNITE ANATOMIC PROXIMAL BODY REMOVED. REPLACED WITH DELTA X-TEND REVERSE IMPLANTS. REVISION OCCURRED (B)(6) 2025. SIGNIFICANT METALLOSIS IN PATIENT WAS NOTICED AND IMPLANTS WILL BE CLEANED BY THE HOSPITAL TO BE SENT FOR INVESTIGATION.

  Patient problems: Foreign Body Reaction

  MAUDE report 23291044 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNITE PROXIMAL BODY, HEAD, AND ANCHOR PEG GLENOID WERE REMOVED TO CONVERT TO A REVERSE TOTAL SHOULDER BECAUSE OF SUBSCAPULARIS DEFICIENCY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22608446 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN TO REVISE AN ANATOMIC TSA TO A REVERSE TSA. PATIENT HAD A FAILED ROTATOR CUFF WHICH REQUIRED REVISION NO IMPLANT COMPLICATIONS. NO PATIENT DELAY. NO HARM TO PATIENT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22151076 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S ROTATOR CUFF BECAME UNSTABLE. SURGEON REVISED FROM AN ANATOMIC TO A REVERSE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21257058 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUBSCAP FAILURE. IT WAS CONVERTED TO REVERSE KEPT DISTAL STEM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20800468 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR SHOULDER PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 20182090 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISE REVISED DUE TO PAIN. AND IT HAS APPEARED TO TEAR ROTATOR CUFF. PLAN IS TO CONVERT PATIENT TO REVERSE TSA. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19721486 ↗
• InjuryApr 3, 2024Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD TOTAL SHOULDER EXPLANTED FOR INFECTION. THE GLENOID WAS LOOSE AND WORN. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19034338 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WAS THERE ANY SURGICAL DELAY? NO ADDITIONAL TIME.

  Patient problems: Joint Laxity

  MAUDE report 18950362 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2023. (RIGHT SHOULDER). TREATMENT: REMOVAL OF OSTEOPHYTES AND SUBSCAPULARIS REPAIR.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 18857855 ↗
• MalfunctionNov 14, 2023No Apparent Adverse Event; No Apparent Adverse Event

  CLINICAL ADVERSE EVENT RECEIVED FOR GLENOID FRACTURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: 18 DEC 2020. (RIGHT SHOULDER). TREATMENT: NONE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18129548 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17747352 ↗
• InjuryAug 1, 2023Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  PATIENT REVISED FOR A SUBSCAP TEAR AND LOOSENING OF THE ANCHOR PEG GLENOID AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. GLENOID WAS SLIGHTLY LOOSE FROM SUPERIOR WEAR. THE HEAD WAS SWAPPED AS WELL. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17434128 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S TOTAL SHOULDER WAS REVISED DUE TO CUFF TEAR. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16876654 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE EXPLANTED AND A CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16856877 ↗
• InjuryFeb 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO LOOSENING OF THE GLENOID COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE TOTAL SHOULDER IMPLANTS WERE REMOVED AND A DEPUY DELTA EXTEND REVERSE WAS DONE. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16447745 ↗
• InjuryFeb 22, 2023Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  PRIMARY RIGHT TOTAL SHOULDER REPLACEMENT DONE IN 2015. REVISION OF GLOBAL AP AND APG+ DUE TO GLENOID LOOSENING/?INFECTION/ ROTATOR CUFF DEFICIENCY. SPECIMENS OBTAINED AND SENT TO THE LAB. GLOBAL AP HUMERAL HEAD REMOVED. APG+ REMOVED SIZE 48MM POSTERIOR WEAR OF APG IMPLANTED NOTED. NO NOTES AVAILABLE FROM ORIGINAL OPERATION SO ALL NUMBERS PROVIDED ARE WHAT WERE VISIBLE ON THE REMOVED IMPLANTS. DOI: 2015. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16417686 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN SHOULDER REGION AFTER SHOULDER REPLACEMENT; CHRONIC PAIN EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2020 (RIGHT SHOULDER). TREATMENT: INITIAL WORK UP FOR INFECTION WITH BLOOD WORK.

  Patient problems: Loss of Range of Motion; Nerve Damage; Numbness; Pain; Paresthesia; Unspecified Infection

  MAUDE report 15951417 ↗